Phase 4
N=65
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
High Triglycerides · Hypercholesterolemia · Schizophrenia · Schizoaffective Disorder · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00833976 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Change in Triglycerides From Baseline to 16 Weeks — -54.13 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lovaza (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Triglycerides From Baseline to 16 Weeks |
-54.13 | — |
| SECONDARY Change in Total Cholesterol From Baseline to 16 Weeks |
-1.75 | — |
| SECONDARY Tolerability of Omega-3 Fatty Acid Capsules (Lovaza) |
1; 22 | — |
Summary
This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.
Eligibility Criteria
Inclusion Criteria
- Female or male patients, 18-75 years of age.
- Serum triglycerides >200 mg/dl or high cholesterol >250 mg/dl
- Current use of an atypical (second-generation) antipsychotic medication - including clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega) - for at least three months
Exclusion Criteria
- Current use of triglyceride or cholesterol-lowering medication other than a statin
- Current use of omega-3 fatty acid supplement
- Intake of fish more than twice per week
- Currently pregnant, or breastfeeding
- Known hypersensitivity or allergy to omega-3 fatty acids (or any fish allergies)
- Current use of anticoagulant medication, except for 1 baby aspirin/day - 81mg (coumadin, heparin, Plavix. etc).
- Consumption of alcohol greater than two drinks per day or active substance abuse
- Any medical condition that would make participation in the study unsafe, as determined by investigator
Data sourced from ClinicalTrials.gov (NCT00833976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.